| Method of preventing relapse in the abstinent substance dependent individual -> Monitor Keywords |
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  Method of preventing relapse in the abstinent substance dependent individualRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Heterocyclic Carbon Compounds Containing A Hetero Ring Having Chalcogen (i.e., O,s,se Or Te) Or Nitrogen As The Only Ring Hetero Atoms Doai, Hetero Ring Is Seven-membered Consisting Of Two Nitrogens And Five Carbon Atoms, Polycyclo Ring System Having The Seven-membered Hetero Ring As One Of The Cyclos, Bicyclo Ring System Having The Seven-membered Hetero Ring As One Of The CyclosThe Patent Description & Claims data below is from USPTO Patent Application 20060172998. Brief Patent Description - Full Patent Description - Patent Application Claims
BACKGROUND OF THE INVENTION [0001] Alcohol and substance dependence are considered to be among the top three disorders in the United States and are associated with serious medical and economical consequences. While alcohol has been recognized as a disease for some time, only recently have we begun to realize that it fits into the same pathways as other addictions. Treatment strategies for the most part have been psychological in nature although pharmacological options are now available in combination with psychological interventions with some additional success. Recently, there have been studies focusing on the reduction of drinking vs. abstinence as an end point. There have also been new issues raised as to predictors of outcomes and adherence to the treatment strategies. These issues along with new technologies and other pharmacological options for the treatment of alcohol and other substance use dependency are part of the innovations this application. [0002] Psychosocial therapies, despite some demonstrated efficacy, are of limited benefit for a substantial proportion of substance abusers in the different phases of their illness. Medications can augment the effects of psychosocial therapies, increasing the proportion of patients who may respond well to treatment. For example, Disulfiram, the deterrent medication that was approved more than 50 years ago for the treatment of alcoholism, has not consistently been shown to be efficacious. However, it does work in the well motivated patient as an assist to curb impulse use. Recent interest in medications to treat alcoholism has yielded a number of promising candidates. In 1994, Naltrexone, an opioid antagonist, was approved by the FDA. Its success requires a program of education that addresses the reluctance of many treatment providers to consider medications as a key ingredient in alcoholism treatment. Naltrexone, for example, has not been widely prescribed. Variable findings of efficacy, possibly due to limited compliance with oral Naltrexone therapy, appear to limit the drug's clinical acceptability. Recently a long-acting formulation of Naltrexone, not yet released, has been found to enhance the beneficial effects of a psychosocial intervention in the treatment of alcohol dependence. If this monthly injection is accepted it may represent a useful addition to the therapeutic armamentarium for alcoholism. [0003] Treatment attrition and non-adherence to programmatic regimens are major barriers to adequate response to effective treatments. As is well recognized, treating substance dependent patients is complex, as they frequently fail to follow through with prescribed treatments. It is also well documented that substance dependent patients irregularly attend clinic visits and many discontinue treatment prematurely. As the FDA approves pharmacological therapies for use in the rehabilitative phase of the treatment of alcohol dependence, treatment adherence may be further compromised when patients skip medication doses, or fail to return for prescription renewals--as evidenced in studies of Naltrexone where fewer than 61% of alcohol dependent patients consistently took their oral dose of medication over a twelve-week course of treatment. [0004] This negative impact on outcomes of patient non-adherence to treatment, i.e., not showing up at treatment sessions, skipping medication dosages, etc. is clear. Predictors of non-adherence and new approaches to monitoring non-adherence are part of the treatment adherence intervention being designed by the Government. most recent work targets the development of both pharmacological technology and psychosocial interventions that compel medication adherence and treatment retention in patients with alcohol dependence. [0005] Alternatively, the inventive concept in this application uses an entirely different strategy by putting control back in the patients' hands. This new treatment technology avoids all coercion by being voluntary, spontaneous, truly at the will of the patient, and provides almost instantaneous calming of any inner disquiet, inner tremors or inner shakiness. [0006] This invention takes advantage of several aspects. [0007] It is known that drug dependency is a multistage disease, having numerous medical, psychological, psychosocial, and treatment phases. These phases include, for example, such obvious ones as acute intoxication, delirium, detoxification, withdrawal, post withdrawal syndrome, early recovery phase, etc. [0008] After a patient undergoes initial detoxification from, for example, an acute alcohol intoxication, there is always a tendency for a patient to relapse. This is quite an issue because the patient with, for example, an alcohol dependency is a different person when compared to a normal person who is not under the influence of other substances. The normal person can drink or not drink, that is, socially, without the crucial differences of loss of control and adverse consequences. The patient with alcohol dependency continues to drink in spite of adverse consequences, such as drunk driving, getting fired from employment, domestic altercations, change in personality and memory blackout that may occur. These alcohol related events are not understood but their occurrence appears to include a genetic element for most people. It is not so much an overdose of the substance as much as a poorly understood consequence of its effect in the brain in the susceptible individual. [0009] There are effective pharmacological treatments for alcohol detoxification and detoxification and the rest of the sedative hypnotics but the pharmacological therapy prevention of a relapse of the patient is not well treated. There is one set of medications that deals with the craving of alcohol, believing that if one diminishes the craving, one can reduce the chance for relapse. Two such medications are known as Naltrexone and Acamprosate. There are deterrents such as Antabuse, Disulfiram. If this deterrent is taken in the morning and one drinks in the afternoon, one gets deadly sick and that is believed to extinguish one's wish to drink because of the fear of getting sick. [0010] Then there are the concepts that a person perhaps experiences a relapse because of being the subject of depression, anxiety or other psychiatric issues. A prophylaxis for this event would be to administer antidepressants and anti anxiety medications. The phenomenon of a relapse is still not understood. [0011] A relapse is associated with an ongoing abstinent state long after completion of a physiological withdrawal from any metabolic, addictive or dependent conditions. This state of relapse vulnerability is yet poorly characterized physiologically, metabolically, biochemically, or neurochemically, for each of the drug or alcohol conditions subsumed in this patent application. This state of vulnerability is nevertheless clearly evident to all families and caregivers of such patients for months and months after detoxification and "rehabilitations" treatment for substance abuse. The relapsing nature of these disorders and the lack of any effective treatment for this disease of the illness are all too apparent to society. [0012] The above analysis of phases of substance abuse as alcoholism as an example because it is most prevalent. Alcohol is easily available and at a relative low cost. Alcohol is socially acceptable as a social drink as long as it is consumed in moderation. However, the problem is, that a large portion of the population abuses the use of alcohol resulting in adverse effects as was described above. [0013] There are many medications or substances which are abused or to which individuals become dependent resulting in the same or similar adverse consequences as were noted above. Such substances are Benzodiazepines, including Librium, Valium, Xanax and Ativan, Marijuana, other sedative hypnotics such as Barbiturates, Doriden, Miltown, Soma, Quaaludes,; Baclofen, GHB, Neurontin or other GABA active drugs. This application and treatment will be applicable to dependency conditions involving any of these substances or categories of substances. BRIEF DESCRIPTION OF THE INVENTION [0014] Flumazenil has been in the medical literature for at least 15 to 20 years. It is a Benzodiazepine antagonist, a receptor blocker that blocks the action of Librium, Valium, Xanax, Ativan, or other Benzodiazepines These medications are addictive and create a dependency in themselves. It turns out that there is a receptor in the brain for these molecules, the Benzodiazepine receptor. [0015] Flumazenil blocks the Benzodiazepine receptor, or, in the alternative, if one has taken one of these medications (one of the Benzodiazepines) and if Flumazenil is given to a patient, it will push out these molecules, and will place the patient into an instant withdrawal state. Thus, Flumazenil is routinely used in an emergency room setting when people have overdosed and almost kill themselves. Intravenous Benzodiazepines are used in an operating room as rapid anesthetics to put people to sleep and in a reverse action Flumazenil is used to wake them up. [0016] Flumazenil is a medicine used to reverse the effects of Benzodiazepines (e.g. diazepam and temazepam) which are often used to induce sedation prior to minor outpatient surgical procedures. [0017] The Benzodiazepines work by acting on receptors in the brain (GABA receptors) causing the release of a chemical called GABA (gamma amino butyric acid). GABA is a major inhibitory chemical in the brain involved in inducing sleep and control of trembling. Benzodiazepines act by increasing the activity of GABA, thereby reducing the functioning of certain areas of the brain. This results in sleepiness, a decrease in shaking and relaxation of muscles. [0018] Flumazenil reverses the effects of Benzodiazepines by competing with them for the GABA receptors. Flumazenil binds to the receptors, preventing Benzodiazepines from acting on them. This blocks their effect and causes sedation to be reversed. [0019] Flumazenil is used to reverse general anesthesia or sedation induced by Benzodiazepines for short term procedures and sedation of patients in intensive care. [0020] This invention uses this medication for a new use in a surprising new methodology, a convenient nasal spray delivery device, never before used for this medication, and for a stage of illness of a group of diseases never before dreamed of, under the unheard of control of the patient, with excellent clinical results. [0021] To prevent the relapse to the urges of a substance under the control of a patient through a novel treatment via a novel route is remarkable. DETAILED DESCRIPTION OF THE INVENTION Continue reading... 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